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Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helsinn Healthcare SA
ClinicalTrials.gov Identifier:
NCT00828295
First received: January 22, 2009
Last updated: March 17, 2015
Last verified: July 2014
Results First Received: June 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Postoperative Nausea and Vomiting
Intervention: Drug: palonosetron

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

First patient enrolled: 19 August 2008. Last patient completed: 27 December 2008.

A total of 12 Investigators from two countries (Russia and Ukraine) participated in the study. The study was conducted at 4 sites in Russia and 8 sites in Ukraine.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
1 mcg/kg Arm

Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)

palonosetron: palonosetron IV 1 mcg/kg

3 mcg/kg Arm

Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)

palonosetron: palonosetron 3mcg/kg IV


Participant Flow:   Overall Study
    1 mcg/kg Arm   3 mcg/kg Arm
STARTED   75   75 
COMPLETED   75   75 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1 mcg/kg Arm

Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)

palonosetron: palonosetron IV 1 mcg/kg

3 mcg/kg Arm

Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)

palonosetron: palonosetron 3mcg/kg IV

Total Total of all reporting groups

Baseline Measures
   1 mcg/kg Arm   3 mcg/kg Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 75   75   150 
Age, Customized 
[Units: Participants]
     
<2 years   3   4   7 
2 to <6 years   18   16   34 
6 to <12 years   29   33   62 
12 to <17 years   25   22   47 
Gender 
[Units: Participants]
     
Female   29   29   58 
Male   46   46   92 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   0   0 
White   75   75   150 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
Ukraine   48   49   97 
Russian Federation   27   26   53 


  Outcome Measures
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1.  Primary:   Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively   [ Time Frame: 0-72 hours post-operatively ]

2.  Secondary:   Proportion of Patients With Complete Response 0-24 Hours   [ Time Frame: 0-24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Salvatore Chessari
Organization: Helsinn Healthcare SA
phone: +41 91 985 21 21
e-mail: salvatore.chessari@helsinn.com



Responsible Party: Helsinn Healthcare SA
ClinicalTrials.gov Identifier: NCT00828295     History of Changes
Other Study ID Numbers: PALO-07-29
Study First Received: January 22, 2009
Results First Received: June 27, 2014
Last Updated: March 17, 2015
Health Authority: United States: Food and Drug Administration
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health